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FDAClass II · Drug · Recalled July 8, 2026

BD ChloraPrep Hi-Lite Orange recall — CareFusion 213, LLC

Hazard: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID
D-0643-2026
Brand
CareFusion 213
Classification
Class II
Units affected
1,800 units
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Description

BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as a) 100 x 10.5 mL applicators/case, NDC 54365-400-35, Catalog Number: 930715NS; b) 100 x 10.5 mL applicators/case, Catalog Number bulk 930715NSB, NDC 54365-400-35; STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co.

Affected products

Companies & origin

Recalling firm location
El Paso, TX, United States
Firm address
1550 Northwestern Dr, N/A, 79912-8000

Identifying details (verbatim from the notice)

Product codes / lots
Lot: a) 3362296, expires: 12/31/2026, 4066870, expires: 02/28/2027, 4104107, expires: 03/31/2027, 4276125, expires: 09/30/2027; b) 4080695, expires: 03/31/2027, 4233300 expires: 08/31/2027.
Distribution
Distributed Nationwide in the USA
Firm notified the public via
Letter
FDA event ID
99217
Recall initiated
June 11, 2026
FDA classified
June 29, 2026
FDA report date
July 8, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.

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